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Saxagliptin

Active substance: saxagliptin

TABLET, FILM COATED · SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE 5 mg/1

United StatesActive

Marketing holder: Mylan Pharmaceuticals Inc.

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 4
  • Komboglyze
    metformin hydrochloride, saxagliptin hydrochloride
    EMEA/H/C/002059
    AstraZeneca AB 
  • Onglyza
    saxagliptin
    EMEA/H/C/001039
    AstraZeneca AB
  • Qtern
    saxagliptin, dapagliflozin propanediol monohydrate
    EMEA/H/C/004057
    Astra Zeneca AB
  • Qtrilmet
    metformin hydrochloride, saxagliptin, dapagliflozin
    EMEA/H/C/004910
    AstraZeneca AB
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-9b07-7485-88a6-39cdc496882c,01a1208d-8ef9-74ee-b614-1b580c27a043,01a12092-6276-7587-be0c-bba529dc7012,01a12094-4017-70f9-9525-48e547fc882b,01a12097-0e9a-7e71-8738-a1b04d523179;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0378-4706
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 0378-4706 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0378-4706 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0378-4706 · Verified 2026-10-09 · open in source